Prosecution Insights
Last updated: April 19, 2026
Application No. 18/402,910

INHIBITORS OF THE IRE-1/XBP-1 PATHWAY AND METHODS OF USING THEREOF

Final Rejection §112§DP
Filed
Jan 03, 2024
Examiner
DICKINSON, PAUL W
Art Unit
1618
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
H. Lee Moffitt Cancer Center and Research Institute, Inc.
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
3y 4m
To Grant
72%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
646 granted / 1025 resolved
+3.0% vs TC avg
Moderate +10% lift
Without
With
+9.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
43 currently pending
Career history
1068
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
42.0%
+2.0% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1025 resolved cases

Office Action

§112 §DP
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION Applicant’s arguments, filed 11/7/2025, have been fully considered but they are not deemed to be fully persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Allowable Subject Matter The closet prior art is Shiraish (Highly sensitive cyanide anion detection with a coumarin–spiropyran conjugate as a fluorescent receptor, Chem. Commun., 2011, 47, 4953–4955). Although Shiraish discloses in Scheme 1 the following compound PNG media_image1.png 90 195 media_image1.png Greyscale , this compound and the disclosure of Shiraish fail to teach or fairly suggest the present compound as presented in claims 1-14. Claims 1- 14 are allowed. Rejoinder Claims 1-14 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 15-24 are directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 2/28/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. New Grounds of Rejection Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 15-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is insufficient written description for the recitation in claim 14 “a method for treating an oncological and/or inflammatory disorder“ by administration of a composition comprising compound 1. Although the specification at page 42, line 12 to page 43, line 15 enumerates many oncological diseases, and at page 43, lines 16-19 enumerates many inflammatory diseases, oncological diseases and inflammatory diseases are difficult to treat across the scope of “oncological and/or inflammatory diseases” as claimed. Cancer agents are often effective against one type of cancer but not another due to the extreme molecular, genetic, and environmental diversity of tumors. For example, administration of an agent that treats a liquid cancer, such as leukemia, for example, is not necessarily predictive of that same agent on solid tumors, such as neuroendocrine cancer. Further regarding inflammatory diseases, inflammation is not a single, uniform process, but is a highly specialized immune response involving different cells, molecular pathways, and mediators depending on cause, location , and type of tissue damage. For example, administration of an agent that that treats the anti-inflammatory disease rheumatoid arthritis (an autoimmune disease) would not necessarily be expected to treat the very different anti-inflammatory disease familial cold autoinflammatory syndrome (an autoinflammatory disease). There is no guidance or protocols provided in the application as to a method of treating oncological diseases across the scope of “oncological diseases,” no guidance or protocols provided in the application as to a method of treating “inflammatory diseases,” nor guidance or protocols provided in the application as to a method of treating a combination of oncological and inflammatory conditions. For this reason, the artisan would not have possession of the invention at the time the invention was filed. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PAUL W DICKINSON/Primary Examiner, Art Unit 1618 February 20, 2026
Read full office action

Prosecution Timeline

Jan 03, 2024
Application Filed
Aug 03, 2025
Non-Final Rejection — §112, §DP
Nov 07, 2025
Response Filed
Feb 21, 2026
Final Rejection — §112, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
72%
With Interview (+9.5%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 1025 resolved cases by this examiner. Grant probability derived from career allow rate.

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